12:00 AM
Nov 13, 2006
 |  BioCentury  |  Politics, Policy & Law

Populist peril

Some things change, some remain the same. Following last week's mid-term elections in the U.S., the biggest challenge to new drug development in Washington remains the same as it was under Republican leadership: regulatory reform.

What has changed is the likelihood that things won't go well. Indeed, after a nine-year run of efforts to stimulate regulatory innovations that support therapeutic innovation, the tide looks to be moving even more toward the agenda of regulatory reformers whose nostrums to protect the public arguably would delay or prevent new treatments from reaching the bedside.

The mid-term elections have resulted in three key shifts. Two are obvious: the Democrats control both houses of Congress, while some important industry supporters from the Republican Party will be gone when the 110th Congress convenes in January.

Less widely appreciated - but probably equally important - is the strengthening of a broad swath of both Republicans and many freshman Democrats who represent the populist streak that has long run through American politics.

Many of the freshman Democrats, especially in the House, are as conservative as the Republicans they defeated and are united with more liberal incumbents by little more than criticism of the conduct of the war in Iraq.

On the other hand, economic populism is one perspective that most of the newly minted members of Congress share with other members of their caucus - and importantly with a like-minded collective of their Republican counterparts.

Even if Sen. Charles Grassley (R-Iowa) is no longer a committee chairman, many of these lawmakers look prepared to continue his campaign to protect the little guy against price gouging and an industry they believe puts profits over patient safety.

Thus, despite myriad other political differences, on healthcare issues these politicians are likely to back the old-line liberal Democrats who will be chairing key congressional committees and will have a raft of industry-bashing issues teed up when they reclaim power.

The Washington offices of pharmaceutical and biotech companies are warning their CEOs to prepare to testify before Congress about a wide range of issues, including off-label marketing, allegations that their firms covered up safety risks, and charges of price gouging.

Given their strong antipathy toward the pharma industry, Democrats will find irresistible the prospect of publicly humiliating the industry, according to biotech and pharmaceutical lobbyists who voiced their views to BioCentury last week.

With a lame-duck President Bush in the White House, and a presidential campaign already underway for 2008, the rhetoric is almost certain to become more shrill.

In this new political landscape, conventional divisions into liberal and conservative, Democrats and Republicans, will be of little help in navigating or influencing policy.

Nevertheless, it is clear that the political upheaval in Washington will accelerate congressional efforts to manage drug prices, to create a pathway for follow-on biologics, and to lower the barriers to drug importation.

With only limited political capital, the best bet for biotech and pharma may be to try to take pragmatic approaches on some issues that are political losers, while investing in critical path issues such as renewal of the Prescription Drug User Fee Act.

Drug importation, Medicare drug pricing, and FOBs are issues that could be managed in ways that mitigate...

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